Arthrex® AR-1390TCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867015593), received between May 30, 2019 and Jan 10, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SCREW/THREAD DID NOT GRIP WHEN SCREWING IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125241 ↗
• MalfunctionNov 26, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SCREW COULD NOT BE SCREWED IN BECAUSE IT DID NOT GRIP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE TIGHTROPES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785630 ↗
• MalfunctionSep 17, 2024Break; Break

  ON 09/5/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1390TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW TIP BROKE OFF. EVERYTHING WAS REMOVED FROM THE PATIENT, AND A NEW SCREW WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238834 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT BROKE INTO HALF WHILE SCREWING IT IN. THE BROKEN PARTS WERE REMOVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816730 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT BROKE INTO HALF WHILE SCREWING IT IN. THE BROKEN PARTS WERE REMOVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809475 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE IMPLANT BROKE INTO HALF WHILE SCREWING IT IN. THE BROKEN PARTS WERE REMOVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809223 ↗
• MalfunctionMay 7, 2024Unstable; Unstable

  ON 6/24/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1390TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW DOES NOT SEAT WELL, LEAVING THE LIGAMENT REPAIR UNSTABLE. SURGEON ALSO NOTICED THAT ONE OF THE THREADS ON THE SCREW WERE FLAT. ANOTHER SCREW IS OPENED AND CASE IS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY AND ACL PROCEDURE ON 6/2/2022 ADDITIONAL INFORMATION RECEIVED ON 6/27/2022: SURGEON USED AR-4030C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19257658 ↗
• MalfunctionJan 9, 2023Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SCREW HEAD BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16120567 ↗
• MalfunctionMay 31, 2022Break; Material Deformation

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1380TC FULL THREAD CANNULATED BIO-COMPOSITE INTERFERENCE SCREW AND AN AR-1390TC FULL THREAD CANNULATED BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING TENSIONING. SURGEON STATED THE SCREWS SHOWED SOME TYPE OF DEFORMATION, WHICH HAS BEEN SEEN BEFORE IN OTHER SURGERY BUT THE SCREWS HAVE NEVER BROKEN BEFORE. SURGEON USED A FOURTH SCREW FROM A DIFFERENT LOT NUMBER THAN THE PERVIOUS ONES AND COMPETED THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION UNDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547246 ↗
• MalfunctionMay 9, 2022Break

  ON 4/19/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1390TC INTERFERENCE SCREW BROKE IN HALF WHEN IT WAS INSERTED AND ATTEMPTED TO BE SCREWED IN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336156 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY MULTIPLE SCREWS BROKE OR CRUMBLED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 13-NOV-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE HE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENTS OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819203 ↗
• InjuryMay 30, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL PROCEDURE IN NOVEMBER 2017 WHERE ARTHREX PRODUCTS WERE IMPLANTED. THE SURGEON USED A BIO-COMPOSITE 9X28 INTERFERENCE SCREW, AR-1390TC, IN THE TIBIA AND A BTBT TIGHTROPE, AR-1588BTB-J, IN THE FEMUR. POST-OP, THE PATIENT PRESENTED WITH ¿APPARENT ABSCESS AND TIBIAL OSTEOMYELITIS¿. THE ABSCESS WAS WASHED OUT AND CULTURED. ALL CULTURES CAME BACK NEGATIVE. A MICRO EXAM CONFIRMED THERE WERE MANY GIANT CELLS, INDICATING A FOREIGN BODY REACTION. ALL BLOOD TEST NORMAL AS WELL. A REVISION PROCEDURE WAS PERFORMED AND WHEN THE SURGEON WENT BACK IN, THE SCREW WAS COMPLETELY MUSH. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE ORIGINAL PROCEDURE THAT WAS PERFORMED WAS AN ACL RECONSTRUCTION ON (B)(6) 2017. THE PATIENT PRESENTED WITH PAIN AND AN APPARENT ABSCESS AND TIBIAL OSTEOMYELITIS AT ABOUT 1 YEAR POST-OP. A REVISION PROCEDURE WAS PERFORMED (DATE UNKNOWN AS THE SALES REP WAS NOT AWARE OF THE SECOND SURGERY) AND THE BIO-COMPOSITE 9X28 INTERFERENCE SCREW, AR-1390TC, WAS REMOVED FROM THE PATIENT. A DEVICE FROM ANOTHER MANUFACTURER WAS THEN IMPLANTED. NOTE: SINCE DATE OF REVISION SURGERY IS UNKNOWN, THE DATE OF E

  Patient problems: Abscess; Failure of Implant; Pain; Unspecified Infection

  MAUDE report 8654908 ↗